ARNUITY ELLIPTA

The pharmacokinetics of fluticasone furoate was characterized in trials of fluticasone furoate given as a single component and in trials of fluticasone furoate given in combination with vilanterol. Linear pharmacokinetics was observed for fluticasone furoate (200 to 800 mcg). On repeated once-daily inhalation administration, steady state of fluticasone furoate plasma concentration was achieved after 6 days, and the accumulation was up to 2.6-fold as compared with single dose.

AbsorptionFluticas...

The safety and efficacy of ARNUITY ELLIPTA were evaluated in 3,611 adult and pediatric subjects aged 12 years and older with asthma. The development program included 4 confirmatory trials of 3 and 6 months’ duration and 3 dose-ranging trials of 8 weeks’ duration. The efficacy of ARNUITY ELLIPTA is based primarily on the dose-ranging trials and the confirmatory trials described below. One additional trial evaluated the safety and efficacy of ARNUITY ELLIPTA in 593 subjects aged 5 to 11 years. 14.1 Dose-Ranging Trials Eight doses of fluticasone furoate ranging from 25 to 800 mcg once daily were ...

Systemic and local corticosteroid use may result in the following:

• Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.1 )]
• Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.3 )]
• Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )]
• Reduction in BMD [see Warnings and Precautions ( 5.9 )]
• Growth Effects in Pediatrics [see Warnings and Precautions ( 5.10 )]
• Glaucoma and Cataracts [see Warnings and Precautions ( 5.11 )] Most commo...

ARNUITY ELLIPTA is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] .
• Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate or any of the excipients [see Warnings and Precautions ( 5.8 ), Description ( 11 )...

• Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.1 )
• Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 )
• Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with cau...

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate. Caution should be exercised when conside...